The field of art to which this invention relates is packaging machinery, more specifically, packaging machinery for packaging surgical needles and sutures, and methods of packaging surgical needles and sutures.
Surgical sutures having surgical needles attached to one or both ends are well known in the medical arts. Sutures having a single needle attached to one end are known as single-armed sutures, while sutures having needles attached to both ends are known as double-armed sutures. Sutures not having surgical needles mounted to either end are referred to as unarmed sutures. Double-armed sutures find particular utility in the following types of surgical procedures: cardiac valve replacement surgery, cardiac surgery, and bowel surgery.
In the past, surgical sutures were hand packaged into specially designed suture packages. Typically, the sutures were wound using conventional winding fixtures having winding pins. Although there may have been advantages associated with the hand winding methods of the prior art, one major disadvantage was that they were unnecessarily time consuming. In order to maintain high quality and to reduce costs, manufacturers of surgical sutures and surgical needles have developed high-speed packaging processes for packaging surgical needles and sutures into specially designed packages. Packages for surgical needles and sutures are well know in the art The packages range from simple folder packages to more complex, molded tray packages suitable for automated, high speed winding and packaging processes. A typical tray package has a winding channel in which the suture is contained. Various moveable doors or hinged members are used to cover the winding channel to maintain the wound suture in place. The tray packages typically have a needle park to retain surgical needles that are mounted to one or both ends of the surgical needles. The sutures are wound into the winding channels by mounting the trays in a rotatable nest member, and rotating the nest and tray while using a stylus member to direct and locate the suture in the channel in a wound pattern. Examples of packages which can be used in high speed winding applications are contained in U.S. Pat. Nos. 5,213,210, 5,236,083, 5,284,240, 6,098,796, and 6,135,272, the disclosures of which are incorporated by reference. High speed winding machines for packaging surgical sutures in such surgical suture packages are disclosed for example in U.S. Pat. Nos. 5,664,404 and 6,032,343 which are incorporated by reference.
Although the packaging machines and processes of the prior art are adequate for their intended use, there are certain types of surgical sutures which are particularly difficult to adapt to high speed winding or packaging machine operations. For example, suture for use in cardiac and cardiovascular surgical procedures is very delicate and any damage caused to the suture by handling or packaging can compromise the integrity of the sutures. In addition, it has been difficult to package such sutures in packages using high-speed automatic packaging machinery due in part to the fine gauge of the sutures. Also, it previously has not been possible to package double armed sutures in tray packages using high-speed winding equipment.
Accordingly, there is a need in this art for novel high-speed packaging machinery and processes for packaging surgical needles and sutures. There is a constant need in this are for novel winding apparatuses and methods to provide for high packaging throughputs, while maintaining the quality and integrity of the surgical sutures and the packages.
It is an object of the present invention to provide novel packaging machines and methods to efficiently and effectively load surgical sutures into a tray package having a suture winding channel in such a way that the sutures are not damaged during the loading process, and such that the sutures dispense easily in the field without damage to the suture.
It is further object of the present invention to provide a machine and a process for electronically printing and affixing a cover to a tray package having a suture winding channel with a surgical suture wound in the channel, and then optionally loading the packages with the labels into magazines that are suitable for automatic processing in downstream operations.
Accordingly, an apparatus or machine for winding surgical sutures into tray packages is disclosed. The apparatus has a machine frame having a top, a bottom, sides and an interior. A disc member is rotatably mounted to the top of the frame, the disc member has a periphery, top, a bottom and a side about the periphery of the disc member. There are a plurality of tool nests. Each tool nest is rotatably mounted to the top of the disc member. Each such tool nest has a nest frame, having a top, a bottom and sides. At least two winding pin members extending up from the top of the nest frame. A rotatable tool is mounted to the machine frame, said tool being displaceable downwardly to engage with the pin members on the nest frame, such that rotation of the tool will rotate the tool nest, wherein said rotatable tool has a top and a bottom. A plurality of channel winding pin members extend down from the bottom of the rotatable tool. There is a cam track member that extends down from the bottom of the rotatable tool. The cam track member has a pair of opposed longitudinal sides and a pair of opposed curved ends connecting the longitudinal sides. The cam track member has a first width along the longitudinal sides and a second width along the curved ends, wherein the first width is greater than the second width. A stylus member is movably mounted to the machine frame, for cooperation with the tool nests. The stylus member has a stylus frame having a top, sides and a bottom. A stylus is mounted to the bottom of the stylus frame having a front nose member and a rear heel member separated by a suture opening. The stylus has a top surface and a bottom surface. A door dosing member extends down from the bottom of the stylus frame adjacent to the stylus. The stylus member operatively engages the cam track member. Optionally, the packaging machine has an in-line printer associated therewith for printing package covers, and, a punching apparatus for punching printed covers from a printed strip of cover material.
Yet another aspect of the present invention is the combination of a suture tray package and a packaging machine. The packaging machine has a machine frame having a top, a bottom, sides and an interior. A disc member is rotatably mounted to the top of the frame. The disc member has a periphery, top, a bottom and a side about the periphery of the disc member. There are a plurality of tool nests, each tool nest is rotatably mounted to the top of the disc member. Each tool nest has a nest frame, having a top, a bottom and sides. At least two winding pin members extend up from the top of the nest frame. A rotatable tool is mounted to the machine frame. The rotatable tool is capable of being displaced downwardly to engage with the pin members on the nest frame, such that rotation of the tool will rotate the tool nest The rotatable tool has a top and a bottom. A plurality of channel winding pin members extend down from the bottom of the rotatable tool. There is a cam track member that extends down from the bottom of the rotatable tool. The cam track member has a pair of opposed longitudinal sides and a pair of opposed curved ends connecting the longitudinal sides. The cam track member has a first width along the longitudinal sides and a second width along the curved ends, wherein the first width is greater than the second width. A stylus member is movably mounted to the machine frame, for cooperation with the tool nests. The stylus member has a stylus frame having a top, sides and a bottom. A stylus is mounted to the bottom of the stylus frame. The stylus has a front nose member and a rear heel member separated by a suture opening. The stylus has a top surface. A door closing member extends down from the bottom of the stylus frame adjacent to the stylus. The stylus operatively engages the cam track member. The suture tray package has a top and a bottom. The tray package has a flat base member having a top and an outer periphery. An outer wall extends up from the base member about the periphery of the base member. An inner wall, interior to the outer wall, extends up from the top of the base member, said inner wall has a top, and the inner wall is spaced away from the outer wall to form a suture channel. A plurality of door members extends out from the top of the inner wall over the winding channel, each such door member has a proximal end and a distal end, and opposed sides. There are a plurality of openings between at least some of the door members for receiving channel winding pin members. At least two needle park members extend up from the top of the base member. The needle park members are located interior to the inner wall. The tray package is mounted in a tool nest. The packaging machine of the combination can optionally have an in-line printer associated therewith for printing package covers, and, a punching apparatus for punching printed covers from a printed strip of cover material.
The tray package of the combination can optionally have a cover for mounting to the top of the package.
Still yet another aspect of the present invention is a method of loading and winding a surgical needle and suture assembly into a tray package having a suture channel using the packaging machines of the present invention.
These and other aspects and features and advantages of the present invention will become more apparent from the following description and accompanying drawings.